BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PESARY CUBE W/DRAIN SZ4 41MM

    MDR report key: 7970091 · Received October 16, 2018

    Report

    Report Number
    2523190-2018-00127
    Event Type
    Injury
    Date Received
    October 16, 2018
    Date of Event
    September 28, 2018
    Report Date
    September 28, 2018
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    HHW
    PMA / PMN Number
    K092981
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, THEREFORE THE FAILURE MODE CANNOT BE CONFIRMED. ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT REPORTED TO INTEGRA THAT ON (B)(6) 2018, A 30-CUD4 PESARY CUBE W/DRAIN HAS CAUSED DISCOMFORT, BLEEDING AND LEAKAGE. THE DEVICE WAS IN CONTACT WITH THE PATIENT. REVISION OR MEDICAL INTERVENTION WAS REQUIRED. PATIENT WAS NOT PREPPED FOR SURGERY. NO SURGERY DELAY WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809047 PESARY CUBE W/DRAIN SZ4 41MM M7 - OB-GYN HHW INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1